ZyPREXA IntraMuscular

In the U.S.

• ZyPREXA IntraMuscular
• ZyPREXA Relprevv

Available Dosage Forms:

• Powder for Solution
• Powder for Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Thienobenzodiazepine

It is very important that your doctor check your progress while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

Olanzapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

This medicine may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). Call your doctor right away if you have a rash, red, swollen skin, fever, chills, cough, trouble breathing, swollen glands, or unusual bleeding, bruising, or weakness after receiving this medicine.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Check with your doctor right away if you have any of the following symptoms while receiving this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while receiving this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Olanzapine injection may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, which may lead to falls, fractures, or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause post-injection delirium/sedation syndrome. Tell your doctor right away if you have the following symptoms: convulsions (seizures), dizziness, drowsiness, sleepiness, or confusion as to time, place, or person after receiving the injection.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

Avoid drinking alcohol while you are receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• change in vision
• change in walking and balance
• clumsiness or unsteadiness
• difficulty with speaking
• difficulty with swallowing
• drooling
• impaired vision
• inability to sit still
• loss of balance control
• mask-like face
• muscle trembling, jerking, or stiffness
• need to keep moving
• rapid weight gain
• restlessness
• shakiness in the legs, arms, hands, or feet
• shuffling walk
• slowed movements
• slurred speech
• stiffness of the arms and legs
• tic-like (jerky) movements of the head, face, mouth, and neck
• tingling of the hands or feet
• trembling or shaking of the fingers, hands, or feet
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual weight gain or loss

• Bladder pain
• bloody or cloudy urine
• bruising
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• excessive muscle tone
• frequent urge to urinate
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• itching of the vagina or genital area
• lack of coordination
• large, flat, blue, or purplish patches in the skin
• loss of bladder control
• loss of memory
• lower back or side pain
• muscle tension or tightness
• nervousness
• pain, redness, and swelling at the injection site
• pounding in the ears
• problems with memory
• rhythmic movement of the muscles
• slow, fast, pounding, or irregular heartbeat or pulse
• speaking is less clear than usual
• sticking out the tongue
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• trouble with breathing, speaking, or swallowing
• twitching
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual or incomplete body or facial movements
• weakness of the arms and legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• back pain
• belching
• change in personality
• difficulty having a bowel movement (stool)
• discouragement
• feeling sad or empty
• fever
• heartburn
• increased appetite
• increased cough
• indigestion
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• runny nose
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• thirst
• trouble sleeping
• trouble with concentrating
• watering of the mouth
• weight gain

• Body aches or pain
• chills
• cold sweats
• congestion
• cough
• dry skin
• dryness or soreness of the throat
• false or unusual sense of well-being
• heavy menstrual bleeding
• hoarseness
• joint pain
• lack of feeling or emotion
• leg cramps
• pain in the arms or legs
• sweating
• tender, swollen glands in the neck
• uncaring feelings
• voice change
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take Zyprexa Intramuscular. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These changes may raise the chance of heart and brain blood vessel disease. Talk with the doctor.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid drinking alcohol while taking Zyprexa Intramuscular.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Dizziness, sleepiness, and feeling less stable may happen with this medicine. These may lead to falling. Broken bones or other health problems can happen from falling. Talk with the doctor.
• A very bad and sometimes deadly reaction has happened with Zyprexa Intramuscular. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• Some people who take this medicine may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if Zyprexa Intramuscular is stopped. Sometimes, signs may lessen or go away over time after this medicine is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take Zyprexa Intramuscular or with higher doses. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
• Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these strokes have been deadly. This drug is not approved to treat mental problems caused by dementia. Talk with your doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Zyprexa Intramuscular (olanzapine injection) while you are pregnant.
• Taking this medicine in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn. Talk with the doctor.

Use Zyprexa Intramuscular as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Check your blood sugar as you have been told by your doctor.
• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Restlessness.
• Feeling tired or weak.
• Hard stools (constipation).
• Dry mouth.
• Feeling sleepy.
• Upset stomach.
• Weight gain.
• More hungry.
• Back pain.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Applies to olanzapine: oral tablet, oral tablet disintegrating

Other dosage forms:

• intramuscular powder for solution, intramuscular powder for suspension extended release

Along with its needed effects, olanzapine (the active ingredient contained in Zyprexa Intramuscular) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking olanzapine:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• change in vision
• change in walking and balance
• clumsiness or unsteadiness
• difficulty with speaking
• difficulty with swallowing
• drooling
• impaired vision
• inability to sit still
• loss of balance control
• mask-like face
• muscle trembling, jerking, or stiffness
• need to keep moving
• rapid weight gain
• restlessness
• shuffling walk
• slowed movements
• slurred speech
• stiffness of the arms and legs
• tic-like (jerky) movements of the head, face, mouth, and neck
• tingling of the hands or feet
• trembling or shaking of the fingers, hands, feet, legs, or arms
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual weight gain or loss

• Bladder pain
• bloody or cloudy urine
• bruising
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• excessive muscle tone
• frequent urge to urinate
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• itching of the vagina or genital area
• lack of coordination
• large, flat, blue, or purplish patches in the skin
• loss of bladder control
• loss of memory
• lower back or side pain
• muscle tension or tightness
• nervousness
• pain during sexual intercourse
• pounding in the ears
• problems with memory
• rhythmic movement of the muscles
• slow, fast, pounding, or irregular heartbeat or pulse
• speaking is less clear than usual
• sticking out the tongue
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• twitching
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual or incomplete body or facial movements
• weakness of the arms and legs

Some side effects of olanzapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• back pain
• belching
• change in personality
• difficulty having a bowel movement (stool)
• discouragement
• feeling sad or empty
• fever
• heartburn
• increased appetite
• increased cough
• indigestion
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• runny nose
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• thirst
• trouble sleeping
• trouble with concentrating
• watering of the mouth

• Blemishes on the skin
• body aches or pain
• chills
• cold sweats
• congestion
• cough
• dry skin
• dryness or soreness of the throat
• false or unusual sense of well-being
• heavy menstrual bleeding (periods)
• hoarseness
• joint pain
• lack of feeling or emotion
• leg cramps
• pain in the arms or legs
• pimples
• sweating
• tender, swollen glands in the neck
• uncaring feelings
• voice change
• vomiting